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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06219798
Other study ID # Pathway CKD 4 and 5
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 9, 2024
Est. completion date June 7, 2024

Study information

Verified date May 2024
Source Association d' Utilisation du Rein Artificiel SANTE
Contact Hélène PAGES
Phone 07 56 05 21 24
Email h.pages@aurasante.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The number of incident and prevalent patients with end stage renal disease on dialysis treatment is increasing in France and worldwide. A quarter of dialysis patients are initiating dialysis urgently through central venous catheters and the number of patients registered in the waiting list for renal transplantation before dialysis initiation is very low. This is also reflected in the very low number of pre-emptive renal transplantations. In order to reduce the number of dialysis patients, the French state has induced a national program proposing a multidisciplinary care pathway including the nephrology visits and at least one consultation with a dietitian and a specialist renal nurse in all patients with Chronic Kidney Disease stage 4 and 5. The aim of this single-center retrospective study is to evaluate the influence of the complete, partial or no participation in this program on the evolution of renal function and clinicobiological parameters in this group of patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 7, 2024
Est. primary completion date May 22, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All stage 4 and 5 Chronic Kidney Disease patients that were included in the program from 01/01/2021 to 31/12/2021 in the clinics of AURA SANTE Exclusion Criteria: - Patients without a medical follow up during this year (2021) - Patients with insufficient or no data during the 24 month of follow up period - Active treatment with corticosteroids, cytotoxic or immunosuppressive drugs, ongoing infection, autoimmune disease or active tumor process

Study Design


Intervention

Diagnostic Test:
GFR
Exit of the study due to death, dialysis, or transplantation

Locations

Country Name City State
France Aura Sante Chamalières Auvergne

Sponsors (1)

Lead Sponsor Collaborator
Association d' Utilisation du Rein Artificiel SANTE

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glomerular filtration rate The estimated Glomerular filtration rate is estimated with the CKD-EPI formula adjusted for 1.73m2 of body surface area and produced in ml/min/1.73m2 of body surface area Every 6 months for 24 months
Secondary Patients survival rate Number of deaths during the sudy period Every 6 months for 24 months
Secondary Renal survival rate Number of patients initiating dialysis during the study period Every 6 months for 24 months
Secondary Haemoglobin levels Evolution of haemoglobin levels during the study period in gram/dL Every 6 months for 24 months
Secondary Plasma Calcium levels Evolution of plasma calcium levels during the study period in mg/dL Every 6 months for 24 months
Secondary Plasma Phosphate levels Evolution of plasma phosphate levels during the study period in mg/dL Every 6 months for 24 months
Secondary Plasma parathyroid hormone levels Evolution of plasma parathyroid hormone levels during the study period in pg/ml Every 6 months for 24 months
Secondary Plasma alcaline reserve levels Evolution of plasma alcaline reserve levels during the study period in mmol/l Every 6 months for 24 months
Secondary 24h salt consumption Evolution of salt consumption during the study period in g/24h Every 6 months for 24 months
Secondary 24h protein consumption Evolution of protein consumption during the study period in g/24h Every 6 months for 24 months
Secondary Quality of life score Scores from Evaluation Quality of life,5 dimensions, 5 levels (EQ-5D-5L), the higher the score the better the outcome through study completion, an average of 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06259422 - Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate N/A
Recruiting NCT04226859 - Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation